Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

• ClinicalTrials.gov Identifier: NCT04232696
• Recruitment Status: Recruiting
• First Posted: January 18, 2020
• Last Update Posted: January 25, 2023
• Sponsor: Neuspera Medical, Inc.
• Information provided by (Responsible Party): Neuspera Medical, Inc.

Tracking Information

• First Submitted Date: December 9, 2019
• First Posted Date: January 18, 2020
• Last Update Posted Date: January 25, 2023
• Actual Study Start Date: December 13, 2019
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 14, 2020)

• Phase II Primary Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence episodes. [ Time Frame: Six months ]
  Change in Urinary Urgency Incontinence episodes at six months post-completion of the trial phase, relative to the number of Urinary Urgency Incontinence episodes at baseline prior to the trial phase.
• Phase II Primary Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up. [ Time Frame: Six months ]
  The number of serious adverse events related to the device.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 7, 2021)

• Phase II Change in Quality of Life: Measured from baseline as measured and assessed by the total and subset International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life score. [ Time Frame: 6 and 12 months ]
  Total score (25 min,160 max) with higher score indicating increase impact on quality of life.
• Phase II Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence. [ Time Frame: 12 months ]
  Change in Urinary Urgency Incontinence episodes at 12 months post-completion of the trial phase, relative to the number of Urinary Urgency Incontinence episodes at baseline prior to the trial phase.
• Phase II Urinary Urgency Frequency Change [ Time Frame: 6 and 12 months ]
  Change in voids/day or a return to normal voiding (less than 8 voids/day) compared to baseline.
• Phase II Comprehensive Summary of all Adverse Events [ Time Frame: 6 and 12 months ]
  The incidence of adverse events will be reported.
• Phase II Device Parameter Information Collected [ Time Frame: 6 and 12 months ]
  Device amplitude will be collected in volts.
• Phase II Physician and Subject User Experience Questionnaire [ Time Frame: 6 and 12 months ]
  Physician and subject satisfaction will be obtained by answering questions on the use of the device using a five point scale:strongly agree, agree, neither agree nor disagree, disagree, strongly disagree. Answers towards strongly agree indicate a better outcome.
• Phase II Urinary Tract Symptoms Questionnaire: International Consultation on Incontinence Questionnaire Female & Male Lower Urinary Tract Symptoms Modules [ Time Frame: 6 and 12 months ]
  Change in male/female lower urinary tract symptoms questionnaire. Male questionnaire score ranges from 0-52 and female questionnaire score ranges from 0-48. Higher number indicates worse outcome.
• Phase II Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up. [ Time Frame: 12 months ]
  The number of serious adverse events related to the device.
• Phase II Urinary Output [ Time Frame: 6 and 12 months ]
  Total urinary output as measured by 72-hour bladder diary.
• Phase II Fecal Incontinence Measured by Wexner Scale [ Time Frame: 6 and 12 months ]
  Fecal incontinence as measured by the Wexner Scale compared to baseline. Wexner scale total points 0-20, higher the score the worse the outcome.
• Phase II Patient Global Impression of Improvement [ Time Frame: 6 and 12 months ]
  Patient Global Impression of Improvement measured after implant during follow-up. Single question answered on a seven point scale: very much better, much better, a little better, no change, a little worse, much worse, very much worse. Selection of very much better is the best outcome.

Original Secondary Outcome Measures (submitted: January 14, 2020)

• Phase II Urinary Urgency Frequency Change [ Time Frame: 6 and 12 months ]
  Change in voids/day or a return to normal voiding (less than 8 voids/day) compared to baseline.
• Phase II Change in Quality of Life: Measured from baseline as measured and assessed by the total and subset International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life score. [ Time Frame: 6 and 12 months ]
  Total score 25-160 with higher score indicating increase impact on quality of life.
• Phase II Comprehensive Summary of all Adverse Events [ Time Frame: 6 and 12 months ]
  The incidence of adverse events will be reported.
• Phase II Device Parameter Information Collected [ Time Frame: 6 and 12 months ]
  Device amplitude will be collected in volts.
• Phase II User Experience Questionnaire [ Time Frame: 6 and 12 months ]
  Physician and subject satisfaction will be obtained by answering questions on the use of the device using a five point scale:strongly agree, agree, neither agree nor disagree, disagree, strongly disagree. Answers towards strongly agree indicate a better outcome.
• Phase II Urinary Tract Symptoms Questionnaire: International Consultation on Incontinence Questionnaire Female & Male Lower Urinary Tract Symptoms Modules [ Time Frame: 6 and 12 months ]
  Change in male/female lower urinary tract symptoms questionnaire. Male questionnaire score ranges from 0-52 and female questionnaire score ranges from 0-48. Higher number indicates worse outcome.
• Phase II Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence. [ Time Frame: 12 months ]
  Change in Urinary Urgency Incontinence episodes at 12 months post-completion of the trial phase, relative to the number of Urinary Urgency Incontinence episodes at baseline prior to the trial phase.
• Phase II Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up. [ Time Frame: 12 months ]
  The number of serious adverse events related to the device.
• Phase II Urinary Output [ Time Frame: 6 and 12 months ]
  Total urinary output as measured by 72-hour bladder diary.
• Phase II Fecal Incontinence Episodes [ Time Frame: 6 and 12 months ]
  Change in fecal incontinence episodes compared to baseline.
• Phase II Fecal Incontinence Measured by Wexner Scale [ Time Frame: 6 and 12 months ]
  Fecal incontinence as measured by the Wexner Scale compared to baseline. Wexner scale total points 0-20, higher the score the worse the outcome.
• Phase II Global Impression of Improvement [ Time Frame: 6 and 12 months ]
  Patient Global Impression of Improvement measured after implant during follow-up. Single question answered on a seven point scale from "very much better" to "very much worse"

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
• Official Title: Clinical Study of Neuspera's Implantable Sacral Nerve Stimulation (SNS) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

Brief Summary

Prospective, multi-center, single-arm, seamless phase-pivotal study conducted in participants diagnosed with UUI who have failed or could not tolerate more conservative treatment. The trial will be conducted in two phases.

Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial.

Objective of Phase II: To assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints.

Detailed Description

Neuspera's Implantable Sacral Nerve Stimulation (SNS) System is indicated to treat participants with UUI who have failed or could not tolerate more conservative treatments.

The study will be conducted in two phases: Phase I of the study will be conducted at up to 9 clinical study sites in the US and Europe. Phase II of the study will be conducted in up to 25 clinical sites in the US and Europe, inclusive of the Phase I centers.

Prospective, multi-center, single-arm, seamless phase-pivotal study. Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial.

Objective of Phase II: To assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints. All participants will receive the same length of device stimulation as determined in Phase I testing.

Phase I will enroll up to 55 participants. Phase II will enroll up to 255 participants.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Prospective, seamless two-phased pivotal study design.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Urinary Urgency Incontinence

Intervention

Device: Neuspera Implantable Sacral Nerve Stimulation System

Stimulation of the Sacral Nerve.

Study Arms

Experimental: Neuspera Implantable Sacral Nerve Stimulation System

Implantation of the simulator.

Intervention: Device: Neuspera Implantable Sacral Nerve Stimulation System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 7, 2021): 310
• Original Estimated Enrollment (submitted: January 14, 2020): 210
• Estimated Study Completion Date: April 2024
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Has a Body Mass Index (BMI) between 18 and 40.
2. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.
3. Has failed or was not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification).
4. Has failed or could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.
5. Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimum of one (1) UUI episode per 24-hour period.

Exclusion Criteria:

1. Has a hemoglobin A1c of greater than 8 percent, or has diabetes mellitus with glucosuria.
2. Has diabetic neuropathy.
3. Has interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines, chronic pelvic pain or recurrent symptomatic urinary tract infections.
4. Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident.
5. Has documented urinary retention within 6 months prior to the screening baseline visit date.
6. Has clinically significant bladder outlet obstruction.
7. Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture or cancer.
8. Has primary stress incontinence or mixed incontinence where the stress component predominates or has been treated surgically for stress urinary incontinence within 6 months prior to the screening baseline visit date.
9. Has received tibial nerve stimulation (TNS) in the past 3 months for the treatment of overactive bladder or unwilling to stay off TNS therapy for 12-month period following implant.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Mark C Director of Clinical Research, BS; 408-433-3839; mark.vollmer@neuspera.com

Contact: Courtney Lane VP, Clinical Research and Regulatory Affairs, PhD; 805-856-8141; courtney.lane@neuspera.com

• Listed Location Countries: Belgium, Netherlands, United States

Administrative Information

• NCT Number: NCT04232696
• Other Study ID Numbers: Neuspera Medical (NSM)-004; SANS-UUI ( Other Identifier: Neuspera )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: At this time, there is no plan to share information.

• Current Responsible Party: Neuspera Medical, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Neuspera Medical, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Neuspera Medical, Inc.
• Verification Date: January 2023